Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: Pain, Orofacial
In brief
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
Key facts
- Study ID
- NCT04059172
- Run by
- University of Colorado, Denver
- People needed
- 375
- Starts
- 2019-12-10
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 12 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
- extractions, if required, performed at least 2 weeks before appliance and archwire placement;
- healthy with no significant medical findings;
- no prophylactic antibiotic coverage required;
- currently not taking antibiotics or analgesics;
- no contraindications to the use of acetaminophen or ibuprofen; and
- minimum age of 12 years
You may not qualify if…
- Under the age of 12 or over the age of 80,
- prisoners,
- pregnant women,
- decisionally challenged individuals,
- allergy to either medication,
- history of kidney disease,
- liver damage or disease,
- alcoholism/use of 3 or more alcoholic drinks during study period,
- use of blood thinners,
- stomach ulcers or
- stomach bleeding.
Where it is running
- University of Colorado, School of Dental Medicine — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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